INFINITY™ EVERLAST™ 33684309Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889797074568), received between Jul 19, 2022 and Nov 13, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS UNKNOWN

  Patient problems: Insufficient Information

  MAUDE report 23550239 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS ANKLE (ITAR-2) STUDY. L MEDIAL ANKLE IMPINGEMENT. PERSISTENT PAIN. NARRATIVE OF ADVERSE EVENT: CONTINUED PAIN MEDIAL ANKLE AFTER TAA. PERFORMED DEBRIDEMENT (B)(6) 2022.

  Patient problems: Joint Impingement; Pain

  MAUDE report 23402220 ↗
• InjuryOct 3, 2023Migration; Migration

  CLINICAL STUDY INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2): SUBJECT (B)(6). AS REPORTED: "FACTURE LINES UNDER TALUS PROSTHESIS WITH LOSS OF TALAR HEIGHT. DURING 6 MONTH FOLLOW UP VISIT (B)(6) 2023, EVIDENCE OF TALUS SUBSIDENCE WAS DOCUMENTED IN RADIOGRAPHIC FOLLOW-UP AND CT WAS REQUESTED. THE CT OF THE LEFT ANKLE PERFORMED ON (B)(6) 2023 WAS REVIEWED WITH PATIENT ON (B)(6) 2023 WITH FINDINGS OF FRACTURE LINES UNDER THE TALUS PROSTHESIS WITH LOSS OF TALAR HEIGHT. PHYSICAL EXAMINATION SHOWED MILD LEFT ANKLE TENDERNESS TO PALPITATION AND MODERATE SWELLING. SURGICAL INTERVENTION WAS RECOMMENDED DUE TO FAILED CONSERVATIVE MEASURES. PATIENT WILL REQUIRE REVISION TOTAL ANKLE REPLACEMENT WITH CUSTOM TALAR COMPONENT DUE TO TALUS FRACTURE LOSS OF HEIGHT. "

  Patient problems: Bone Fracture(s); Swelling/ Edema

  MAUDE report 17861147 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A REPORTED WOUND DEVELOPMENT AND SUBSEQUENT INFECTION AT SURGICAL INCISION SITE OF LEFT ANKLE. ANTIBIOTIC COURSES INCLUDING BACTRIM, DOXYCYCLINE, AND LEVAQUIN AS WELL AS WOUND CARE INCLUDING TOPICAL SILVADENE WERE TRIALED. SURGICAL INTERVENTION FOR WOUND DEBRIDEMENT, IRRIGATION, VANCOMYCIN POWDER APPLICATION, AND PLACEMENT OF PICO WOUND VAC DRESSING WERE PERFORMED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17002858 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT CAME INTO SURGEONS OFFICE WITH SWELLING AND REDNESS. THE SURGEON ATTEMPTED TO TREAT BY ASPIRATING THE ANKLE AND TREATED WITH ANTIBIOTICS. INFECTION PERSISTED, SO THE SURGEON REMOVED THE PROSTHESIS AND REPLACED IT WITH AN ANTIBIOTIC SPACER. DUE TO INFECTION AND TIBIAL LOOSENING, PATIENT REQUIRED EXPLANTATION OF PROSTHESIS, IMPLANTATION OF ANTIBIOTIC CEMENT SPACER, AND WILL REQUIRE A REVISION.

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 15059745 ↗